BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA UNIVERSAL

    MDR report key: 1834250 · Received August 26, 2010

    Report

    Report Number
    1834250
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    June 29, 2010
    Report Date
    August 26, 2010
    Manufacturer
    COVIDIEN LP
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER REPORT FROM THE O.R. TEAM: "AUTOSUTURE USED FOR LAP BPD BILIOPANCREATIC DIVERSION CASE. IT HAD BEEN USED X2 WITHOUT INCIDENT. UPON THE 3RD FIRING, A METAL PIECE ON RE-LOAD WAS BENT AND EVENTUALLY FELL OFF INSIDE THE PATIENT. IT WAS RETRIEVED IN ITS ENTIRETY. BOTH GUN AND RELOAD REMOVED OFF FIELD. THE TROCAR THAT GUN WAS INSIDE WAS CRACKED WHEN GUN WAS REMOVED. THIS TROCAR WAS ALSO REPLACED."======================HEALTH PROFESSIONAL'S IMPRESSION======================AS STATED IN THE DESCRIPTION OF THE EVENT (ABOVE). PATIENT WAS FORTUNATELY UNHARMED.======================MANUFACTURER RESPONSE FOR SURGICAL STAPLING DEVICE, ENDO GIA UNIVERSAL - 12MM======================THIS HOSPITAL ENJOYS A GOOD WORKING RELATIONSHIP WITH THE AUTOSUTURE REP. HE IS AWARE OF THIS DEVICE MALFUNCTION, AND HAS REPORTED IT TO HIS COMPANY'S QUALITY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ULTRA UNIVERSAL STAPLER, SURGICAL GDW COVIDIEN LP 030449 N9J0227

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR